UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014037
Receipt No. R000016349
Official scientific title of the study Findings of Rheumascan in patients with rheumatoid arthritis and other arthritis-related diseases
Date of disclosure of the study information 2014/05/28
Last modified on 2016/11/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Findings of Rheumascan in patients with rheumatoid arthritis and other arthritis-related diseases
Title of the study (Brief title) Findings of Rheumascan in patients with rheumatoid arthritis and other arthritis-related diseases
Region
Japan

Condition
Condition rheumatoid arthritis and other diseases which can cause wrist or finger joint symptoms
Classification by specialty
Clinical immunology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore findings specific to rheumatoid arthritis and other diseases by intra- and inter-disease (including healthy subjects) comparison of Rheumascan findings and to investigate usefulness of Rheumascan in differential diagnosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. signal intensity (semi-quantitative evaluation of the signal area in each joint region) and distribution of each joint
2. signal intensity and distribution outside the joint regions
Key secondary outcomes 1. Intra- and inter-disease comparison of Rheumascan findings at the enrollement and 3-6 months later.
2. relationship between rheumascan finidings and the diagnosis 3-6 months later in cases of undetermined diagnosis at the enrollment
3. relationship between Rheumascan findings and radiographic and ultrasonographic findings
4. safety of ICG administration in all cases

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 1. rheumascan examination at the enrollment
2. rheumascan examination 3-6 months after the enrollment (if a patient can be followed up 3-6 months later and written consent is obtained)
3. radiography and ultrasonography of hands at the enrollement and 3-6 months later if clinically indicated
4. clinical examination of both hands (skin and joint findings)
Interventions/Control_2 for healthy volunteers, only rheumascan examination and clinical examination are required
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who can give written consent and fulfill either of the followings
1. 2010 ACR/EULAR RA classification criteria
2. connecitve tissue diseases other than rheumatoid arthritis
3. osteoarthritis, crystal-induced arthritis, complex regional pain syndrome
4. a patient suspected of having any of the above-mentioned diseases
5. healthy volunteers
Key exclusion criteria 1. contraindication of ICG (history of hypersensitive reaction to ICG or iodines)
2. pregnant or breastfeeding
3. a patient considered to be inappropriate for the study by the attending physician
Target sample size 110

Research contact person
Name of lead principal investigator Masaaki Mori
Organization Tokyo Medical and Dental University
Division name Department of Lifetime Clinical Immunology
Address 5-45, Yushima 1-chome, Bunkyo-ku, Tokyo
TEL 03-5903-4677
Email mori.phv@tmd.ac.jp

Public contact
Name of contact person Fumio Hirano
Organization Tokyo Medical and Dental University
Division name Department of Lifetime Clinical Immunology
Address 5-45, Yushima 1-chome, Bunkyo-ku, Tokyo
TEL 03-5803-4677
Homepage URL
Email hirano.rheu@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Department of Lifetime Clinical Immunology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 28 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2014 Year 04 Month 30 Day
Anticipated trial start date
2014 Year 05 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2014 Year 05 Month 22 Day
Last modified on
2016 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016349


For inquiries about the use of UMIN clinical trial registration system, use this contact form .Fort other inquiries, use this contact form